Auxilium Posts Positive Phase 2A Results For Cellulite Drug

Specialty biopharmaceutical company, Auxilium Pharmaceuticals, reported positive results from its Phase IIA study evaluating Xiaflex for treatment of cellulite.

Xiaflex (collagenase clostridium histolyticum, or CCH) is an FDA-approved, orphan drug designated biologic indicated for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord, a disorder that affects the fingers’ range of motion. Auxilium’s application for the approval of Xiaflex for the concurrent treatment of two Dupuytren's cords is under review by the FDA. The drug is currently in Phase II trials for cellulite and Frozen Shoulder syndrome.

Edematous fibrosclerotic panniculopathy (EFP), also known as cellulite, is a metabolic disorder of tissue under the skin. It stems from the loss of elasticity of collagen cords attaching the skin to muscle layers underneath, which in turns causes the characteristic dimpling of cellulite. CCH is under investigation as a therapy that targets and breaks the collagen tethers to release skin dimpling, potentially smoothing the skin.

Results from the Phase IIA study show that all three investigational doses (low (0.06mg), mid (0.48mg), and high (0.84mg)) of CCH improved the appearance of cellulite in the 150 women enrolled in the trial. In the mid and high dose groups, CCH demonstrated a statistically significant improvement in cellulite appearance compared to placebo. Sixty-eight percent of patients in the mid and high dose groups expressed being "Satisfied" or "Very Satisfied" with the CCH treatment compared to 34 percent in the placebo arm of the trial.

James Tursi, CMO of Auxilium Pharmaceuticals, said, “These data have exceeded our expectations, demonstrating statistically significant improvements in cellulite as measured by both physicians and patients. These are challenging endpoints and ones that we believe are critical in the context of regulatory consideration. We are continuing to analyze these exciting data and will be gathering key opinion leader and regulatory input and look forward to publishing and presenting our findings in peer-reviewed venues in the future."

Adrian Adams, CEO and President of Auxilium Pharmaceuticals, said, “We believe these data establish proof-of-concept for CCH as a potential treatment for cellulite and enable Auxilium to pursue our development and regulatory strategy to most efficiently and effectively advance this exciting program.” Adams added that the company plans to launch a Phase IIB clinical study for the treatment set to begin in the second quarter of 2015.